Principal Medical Writer

Company Description

Statistics show that women and underrepresented groups tend to apply to jobs only if they meet 100% of the qualifications. Sobi encourages you to change that statistic and apply. Rarely do candidates meet 100% of the qualifications. We look forward to your application!

At Sobi, each person brings their unique talents to work as a team and make a difference. We are dedicated to developing and delivering innovative therapies to improve the lives of people who live with a rare disease. Our edge comes from our team of people and our commitment to patients.

Our mission and culture at Sobi North America get us excited to come to work every day, but here are a few more reasons to join our team:

• Competitive compensation for your work
• Generous time off policy
• Opportunity to broaden your horizons by attending popular conferences
• Emphasis on work/life balance
• Collaborative and team-oriented environment
• Making a positive impact to help ultra-rare disease patients who are in need of life saving treatments

This role is expected to be based in the San Diego area, and the person should be able to to come into the office a couple of days a week, while maintaining some flexibility

Job Description

As a Principal Medical Writer, you will provide communication expertise and lead a strategy-driven approach to authoring of key clinical and regulatory documents and regulatory submissions, to ensure clarity, credibility and consistency of clinical information throughout submission packages and clinical programs, to facilitate regulatory assessment, and to achieve a product label that fulfills commercial needs.

Key responsibilities:

• Lead a strategy-driven approach to authoring of the clinical components of regulatory submissions, ensuring a clear, concise, complete, credible and compelling scientific content aligned with the objective of the regulatory document.
• Assume primary responsibility for preparation of key clinical and regulatory documents and documents supporting major regulatory submissions as well as responses to regulatory agencies/ health authorities.
• Provide leadership and project coordination to  cross-functional authoring teams, ensuring efficient delivery, high quality, and regulatory compliance of clinical regulatory documents.
• Liaise with senior project staff, prospectively develop a storyboard for the submission, and plan document development to provide optimal support for the proposed prescribing information.
• Assume a Product Medical Writer responsibility, providing strategic medical writing expertise and support to multiple projects in a clinical development program.
• Ensure high technical quality of the documents in compliance with in-house technical requirements.
• Coach and develop less experienced Medical Writers.
• Oversee and coordinate all Medical Writers assisting on documents under your responsibility, including in-house consultants and Medical Writers at CRO.

Qualifications

Qualification and experience:

• Life Science Master´s degree or PhD
• A minimum of 8-10 years' experience in regulatory medical writing combined with scientific and regulatory knowledge, plus in-depth knowledge of regulatory medical writing processes
• Experience in leading complex global regulatory and clinical writing projects, such as complex CSRs, CTDs, ODDs, PIPs, briefing documents and regulatory responses
• Experience in leading writing activities for major US and/or EMA regulatory submissions, including coordinating the work of other Medical Writers and submission leadership
• Clear understanding of clinical development, including the phases, processes, and techniques used within a clinical development environment from protocol design through regulatory submission and support for marketed products
• Advanced knowledge of global regulatory environment and processes (key regulatory bodies, key documents, approval processes, safety reporting requirements)

Skills and personal attributes:

• Excellent written and spoken English skills
• Highly developed analytical and strategic thinking with an ability to identify key issues
• Ability to communicate difficult and complex ideas clearly and effectively to all stakeholders
• Strong interpersonal, communication and influencing skills, ability to co-ordinate work of others
• Strong team player with a proven ability to drive and manage team performance and to work effectively with people of different cultural, functional and seniority backgrounds
• Result-oriented person with excellent problem-solving skills and flexible attitude
• Ability to manage multiple parallel tasks and prioritize tasks under ti